Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jun 13, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment for patients with untreated diffuse large B-cell lymphoma (DLBCL) that has a specific genetic change called MYC rearrangement. The treatment being studied combines a medication called lenalidomide with a chemotherapy regimen known as R-DA-EPOCH. This trial aims to find out how safe and effective this combination is for patients with this challenging condition, as previous treatments have not been very successful.

To participate in the trial, patients need to be between 18 and 60 years old and have a confirmed diagnosis of MYC-rearranged DLBCL. They should be in relatively good health, able to perform daily activities, and have measurable disease that can be evaluated. Participants will be closely monitored throughout the study to assess the treatment's effects and any potential side effects. It's important to note that certain individuals, such as those with active infections, severe heart problems, or previous cancer treatments, may not be eligible to join. If you're interested in learning more about this trial, it’s a good idea to discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma.
• • 2. ECOG PS 0-2
• • 3. Age 18-60 years old
• • 4. Expected survival ≥ 12 weeks
• • 5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
• • 6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
• Exclusion Criteria:
• • 1. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
• • 2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
• • 3. Previous exposure to any anti-tumor therapy
• • 4. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma
• • 5. History of DVT or PE within past 12 months
• • 6. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration
• • 7. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia
• • 8. CNS or meningeal involvement
• • 9. Known sensitivity or allergy to investigational product
• • 10. Major surgery within three weeks
• • 11. Patients receiving organ transplantation
• • 12. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer
• • 13. Presence of Grade III nervous toxicity within past two weeks
• • 14. Active and severe infectious diseases
• • 15. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment
• • 16. In any conditions which investigator considered ineligible for this study
• • 17. Patients with histological transformation.